Histochemical Study of Vitiligo in Sohag University Hospital Patients

NCT05869942 | Unknown

• 1 other identifier: Soh-Med-23-04-25MS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Vitiligo is a common acquired idiopathic disorder characterized by depigmentation of the skin, hair, and mucous membranes in the form of macules and patches due to selective melanocyte destruction . Incidence of Vitiligo is about 0.5% to 2% of the world's population, and its incidence continues to increase. Vitiligo can appear at any age group especially in the second and third decades of life. About one-third of vitiligo patients are children under ten years old Vitiligo can be classified into non-segmental, segmental, mixed and unclassifiable/undetermined types. Vitiligo has a negative impact on patient's quality of life by decreasing their self-confidence and causing significant psychological distress.

Conditions

Vitiligo

Keywords

vitiligo; autoimmunity; apoptosis; melanocytes

Outcome Measures

Primary Outcomes (2)

• Assessment of tissue expression of HMGB1 in patients with vitiligo compared to normal control.

  Monoclonal HMGB1 antibodie assessment by Skin biopsy from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin.

  12 months

• Assessment of tissue expression of active caspase 3 in patients with vitiligo compared to normal

  active caspase 3 antibodie assessment by Skin biopsy from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin.

  12 months

Study Arms (2)

groupA (Diseased group)

ACTIVE COMPARATOR

patients with Vitiligo

Diagnostic Test: Light microscopic studies; Diagnostic Test: Immunohistochemical studies

group B(Control group)

ACTIVE COMPARATOR

Normal control group not diseased

Diagnostic Test: Light microscopic studies; Diagnostic Test: Immunohistochemical studies

Interventions

Light microscopic studies DIAGNOSTIC_TEST

Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin then will be rinsed in physiological saline and fixed in formalin for 24 hours. The preserved tissues will be trimmed for processing, then undergo dehydration with ethyl alcohol, clearing with xylene, infiltration and embedding with paraffin wax. Paraffin wax blocks will be sectioned at 5μ then mounted on glass slides. Sectioned slides will be stained with hematoxylin and eosin and other histological stains and mounted with (DPX). And examined by light microscope. The pathological changes in vitiligenous skin will be detected

group B(Control group); groupA (Diseased group)

Immunohistochemical studies DIAGNOSTIC_TEST

Monoclonal HMGB1 and active caspase 3 antibodies

group B(Control group); groupA (Diseased group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The study will include patients with vitiligo aged 18-50 years old.

You may not qualify if:

• Pregnancy
• Lactation
• Patient on immunosuppressive treatment for vitiligo over the last month
• Skin diseases, other than vitiligo.
• Systemic diseases particulary endocrine disorders and autoimmune connective tissue diseases.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• Bellei B, Picardo M. Premature cell senescence in human skin: Dual face in chronic acquired pigmentary disorders. Ageing Res Rev. 2020 Jan;57:100981. doi: 10.1016/j.arr.2019.100981. Epub 2019 Nov 14.

  PMID: 31733332 BACKGROUND

• Faraj S, Kemp EH, Gawkrodger DJ. Patho-immunological mechanisms of vitiligo: the role of the innate and adaptive immunities and environmental stress factors. Clin Exp Immunol. 2022 Jan 28;207(1):27-43. doi: 10.1093/cei/uxab002.

  PMID: 35020865 BACKGROUND

• Wei G, Pan Y, Wang J, Xiong X, He Y, Xu J. Role of HMGB1 in Vitiligo: Current Perceptions and Future Perspectives. Clin Cosmet Investig Dermatol. 2022 Oct 13;15:2177-2186. doi: 10.2147/CCID.S381432. eCollection 2022.

  PMID: 36267690 BACKGROUND

• Wang J, Pan Y, Wei G, Mao H, Liu R, He Y. Damage-associated molecular patterns in vitiligo: igniter fuse from oxidative stress to melanocyte loss. Redox Rep. 2022 Dec;27(1):193-199. doi: 10.1080/13510002.2022.2123864.

  PMID: 36154894 BACKGROUND

MeSH Terms

Conditions

Vitiligo; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Doha S Mohamed, professor

  Sohag University, Faculty of Medicine

  STUDY CHAIR

• Zeinab A Goda, lecturer

  Sohag University, Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Noha M Ahmed, Demonstrator

CONTACT

01141077957; nohamamdouh@med.sohag.edu.eg

Samira M Mohamed, Lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at Histology and cell Biology department

Model Details: Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin then will be rinsed in physiological saline and fixed in formalin for 24 hours. The preserved tissues will be trimmed for processing, then undergo dehydration with ethyl alcohol, clearing with xylene, infiltration and embedding with paraffin wax. Paraffin wax blocks will be sectioned at 5μ then mounted on glass slides. Sectioned slides will be stained with hematoxylin and eosin and other histological stains and mounted with (DPX). And examined by light microscope. The pathological changes in vitiligenous skin will be detected. Monoclonal HMGB1 and active caspase 3 antibodies assessment.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 22, 2023
• Study Start: June 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: August 15, 2024
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)